Disease Control with Upadacitinib in Patients with Psoriatic Arthritis: A Post Hoc Analysis of the Randomized, Placebo-Controlled SELECT-PsA 1 and 2 Phase 3 Trials

Abstract

Introduction: Low disease activity (LDA)/remission is the target of treatment in patients with psoriatic arthritis (PsA). We assessed the proportions of patients with PsA receiving upadacitinib who achieved LDA/remission over 1 year.

Methods: This was a post hoc analysis of the double-blind, placebo-controlled SELECT-PsA 1 (also adalimumab-controlled) and SELECT-PsA 2 trials. Treatment targets assessed included LDA/remission defined by Disease Activity in Psoriatic Arthritis (≤ 14/ ≤ 4) and Psoriatic Arthritis Disease Activity Scores (≤ 3.2/ ≤ 1.9), as well as minimal disease activity (MDA)/very low disease activity (VLDA) states (5/7 and 7/7 components, respectively, of MDA criteria). Targets were assessed at 24 and 56 weeks. For binary outcomes, non-responder imputation was used for missing data. Data from patients receiving upadacitinib 30 mg was not included in the analysis.

Results: Overall, 1386 patients were analyzed. Disease control (i.e., LDA/MDA) was achieved at 24 weeks in upadacitinib 15 mg-treated patients across both studies: LDA/MDA was achieved by 25-48% of patients receiving upadacitinib 15 mg versus 2-16% of patients receiving placebo, and remission/VLDA rates were 7-14% with upadacitinib 15 mg versus 0-4% with placebo. The proportions of patients achieving treatment targets were numerically similar to upadacitinib 15 mg and adalimumab. All responses were sustained at 56 weeks.

Conclusions: Remission and LDA are feasible targets with upadacitinib treatment in patients with PsA.

Trial registration: ClinicalTrial.gov identifiers NCT03104400 (SELECT-PsA 1) and NCT03104374 (SELECT-PsA 2).

Keywords: JAK inhibitor; Psoriatic arthritis; SELECT-PsA 1; SELECT-PsA 2; Upadacitinib.

© 2022. The Author(s).

Figures

Fig. 1

Proportion of patients achieving DAPSA LDA (A), PASDAS LDA (B), DAPSA REM (C), and PASDAS REM (D) at weeks 24 and 56 (NRI). *Nominal p < 0.05 versus PBO. ADA adalimumab, bDMARD biologic disease-modifying antirheumatic drug, DAPSA Disease Activity in Psoriatic Arthritis, EOW every other week, IR inadequate response, LDA low disease activity, nbDMARD non-biologic disease-modifying antirheumatic drug, NRI non-responder imputation, PASDAS Psoriatic Arthritis Disease Activity Score, PBO placebo, QD once daily, REM remission, UPA upadacitinib. At week 24, all patients who had originally been randomized to PBO were switched to UPA 15 mg QD regardless of response

Fig. 2

Proportion of patients achieving MDA (A) and VLDA (B) at weeks 24 and 56 (NRI). *Nominal p < 0.05 versus PBO. #Statistically significant in the multiplicity-controlled analysis. ADA adalimumab, bDMARD biologic disease-modifying antirheumatic drug, EOW every other week, IR inadequate response, MDA minimal disease activity, nbDMARD non-biologic disease-modifying antirheumatic drug, NRI non-responder imputation, PBO placebo, QD once daily, UPA upadacitinib, VLDA very low disease activity. At week 24, all patients who had originally been randomized to PBO were switched to UPA 15 mg QD regardless of response

Fig. 3

Proportion of patients achieving MDA components among upadacitinib- or adalimumab-treated patients who achieved MDA (A) and did not achieve MDA (B) at week 24 (NRI). ADA adalimumab, bDMARD biologic disease-modifying antirheumatic drug, BSA-Ps body surface area-psoriasis, EOW every other week, HAQ-DI Health Assessment Questionnaire-Disability Index, IR inadequate response, LEI Leeds Enthesitis Index, MDA minimal disease activity, nbDMARD non-biologic disease-modifying antirheumatic drug, NRI non-responder imputation, NRS numeric rating scale, PASI Psoriasis Area Severity Index, PtGA Patient’s Global Assessment of Disease Activity, QD once daily, SJC66 swollen joint count in 66 joints, TJC68 tender joint count in 68 joints, UPA upadacitinib

Fig. 4

Proportion of patients achieving MDA components among upadacitinib- or adalimumab-treated patients who achieved MDA (A) and did not achieve MDA (B) at week 56 (NRI). ADA adalimumab, bDMARD biologic disease-modifying antirheumatic drug, BSA-Ps body surface area-psoriasis, EOW every other week, HAQ-DI Health Assessment Questionnaire-Disability Index, IR inadequate response, LEI Leeds Enthesitis Index, MDA minimal disease activity, nbDMARD non-biologic disease-modifying antirheumatic drug, NRI non-responder imputation, NRS numeric rating scale, PASI Psoriasis Area Severity Index, PtGA Patient’s Global Assessment of Disease Activity, QD once daily, SJC66 swollen joint count in 66 joints, TJC68 tender joint count in 68 joints, UPA upadacitinib